Does something smell funny about the FDA's crackdown on some Zicam nasal products? Lifescript’s Chief Medical Officer weighs in on the ruling and safety of nasal cold remedies…

The U.S. Food & Drug Administration (FDA) yesterday warned Americans to stop using three over-the-counter Zicam nasal cold products because they can cause loss of the sense of smell, a condition called anosmia.

The FDA received more than 130 reports of anosmia over a 10-year period from people who had used Zicam. Consumers also filed more than 800 complaints with Scottsdale, Arizona-based Matrixx Initiatives, which makes the popular cold remedy.

The warning letters generated a lot of traffic on Twitter yesterday. Some noted that 130 cases out of millions of users is fairly low, but the additional 800 cases on file means the risk is higher than originally thought. Zicam posted the warning on its Web site (www.zicam.com) and Twitter page (@Zicam).

It’s a "serious risk for people who use these products for relief from cold symptoms," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are advising them not to use these products for any reason.”

The Truth About ZincZinc taken orally seldom causes side effects other than occasional stomach upset, usually when taken on an empty stomach.

But use of zinc nasal gels and sprays has been linked to anosmia, according to a 2004 study in the American Journal of Rhinology, which also reported that severe pain can occur if the gel is inhaled too deeply.

According to some scientists, zinc may damage nerves in the nose needed for smell. Many people complain of nasal burning or stinging sensations in the nose, and a more rapid onset of symptoms than is seen with post-viral anosmia (the loss of smell following a viral infection, which can be temporary or permanent).

The FDA advises that anosmia can be life threatening; it limits people’s ability to detect the smell of gas, smoke or other signs of danger in the environment. Contact your doctor immediately if you experience loss of sense of smell or other problems after using any zinc-based nasal products.

Consumer BewareTo alert the public, the FDA issued a news release, a public health advisory, a fact sheet about the products and risks, a consumer article and a drug safety podcast. The agency asks health-care professionals and consumers to report possible cases of anosmia or other problems after using these products to the FDA through its MedWatch program, either online or by calling 1-800-FDA-1088.

Even if you’ve had good results with Zicam, the FDA recommends that consumers discard or return any unused product and consult your physician about alternatives.

The agency limited its warning to Zicam nasal gels, and said it didn't receive many reports of anosmia linked to other popular nasal cold remedies. But back in 2004, another zinc-based nasal product, Cold-Eeze, was pulled from stores by its manufacturer after receiving similar complaints.

Matrixx has suspended shipments of the products and said on its Web site that it will reimburse consumers seeking refunds. Even so, the company stood behind the support and efficacy of Zicam, saying it believed there was no causal link between its nasal gels and anosmia.

Why Now?It’s not clear why, after 10 years, the FDA decided to crack down on Zicam, though the move suggests that someone within Matrixx leaked this information to FDA – a possible whistleblower situation. There’s also speculation that the Obama administration is taking a harder line against drug companies than its predecessor.

Natural and homeopathic remedies are not subject to the same rigorous approval process as new drugs. In 2007, however, a new law required manufacturers of these products to report complaints and side effects to the FDA.

The agency has asked Matrixx to turn over “more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products,” according to Deborah M. Autor, director of the agency’s Center for Drug Evaluation and Research.

Bad News for Natural RemediesThe FDA’s warning comes at a time when the use of complementary or alternative remedies is climbing. A survey conducted by the government last December found that 38% of Americans use some type of alternative remedy. More women (43%) take them than do men (34%).

Many remedies are allowed to be marketed and sold without a prescription as long as they:

Are generally regarded as safe

Don't have significant side effects

Don’t make medical claims

Don’t affect the structure or function of the body

Although the FDA isn’t changing its stance about the marketing and sale of homeopathic medicines and other over-the-counter remedies, the agency took action against Matrixx because of claims on its label that deemed Zicam intranasal cold products a “drug” under the Federal Food, Drug and Cosmetic Act.

The manufacturer notes, for example, that the products claim to reduce the duration of the common cold"and the severity of cold symptoms, specifically including "sore throat, stuffy nose, sneezing, coughing and congestion."

Because the claims are “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease,” the product is subject to FDA oversight. The federal agency also noted that Matrixx didn’t establish that its intranasal products were generally recognized as safe.

Worth the Risk?Until the safety of the Zicam products is confirmed, consumers who use them will be taking a risk. For example, it isn't clear from the available data if anosmia develops early in the course of therapy or after prolonged treatment.

Some studies have noted that the elderly, small children and those with kidney failure are at highest risk.

The FDA gave Matrixx 15 days to stop marketing the products and remove them from stores or it would face a recall. Because Matrixx will also have to apply as a new drug and go through the long approval process, it may take years of clinical trials before consumers see Zicam nasal products on supermarket and drugstore shelves again.

How Much Do You Know About Home Remedies?Chicken soup for a cold? Holding your breath to halt your hiccups? Friends and family swear by these common cures. But you're not so sure. You've heard all the age-old remedies, but can you decipher fact from fiction? Find out how much you really know in this home remedy quiz.

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